Oral Health-Related Quality of Life Between Two Different Types of Orthodontic Appliances

NCT ID: NCT06401382

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-02

Study Completion Date

2023-11-03

Brief Summary

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Patients who have mild crowding from the Orthodontic Department at University of Damascus Dental School will be treated in this trial. The effects of modified aligner appliance with NiTi springs on oral health-related quality of life (OHRQoL) compared with conventional fixed appliances using the OHIP-14 questionnaire during orthodontic treatment. So, this study aims to compare the changes in OHRQoL between patients receiving modified aligner appliances or conventional fixed appliances during orthodontic treatment.

There are two groups:

1. Experimental group: the patients in this group will be treated using a modified aligner appliance.
2. Control group: the patients in this group will be treated using conventional fixed appliances

Detailed Description

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Most adult patients do not choose traditional fixed appliances due to concerns about appearance, lengthy treatment time, and challenges with oral hygiene. This study aimed to assess the impact on psychological well-being, aesthetics, and functionality of a novel single aligner appliance.

Conditions

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Crowding of Anterior Mandibular Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Modified aligner appliance with NiTi springs

The patients in this group will be treated using a Modified aligner appliance with NiTi springs.

Group Type EXPERIMENTAL

A modified aligner appliance with NiTi springs

Intervention Type DEVICE

The modified aligner appliance will be used until the final position is achieved.

Conventional fixed appliances

The patients in this group will be treated using conventional fixed appliances.

Group Type ACTIVE_COMPARATOR

Conventional fixed appliances

Intervention Type DEVICE

The traditional fixed appliances with a standard prescription will be used.

Interventions

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A modified aligner appliance with NiTi springs

The modified aligner appliance will be used until the final position is achieved.

Intervention Type DEVICE

Conventional fixed appliances

The traditional fixed appliances with a standard prescription will be used.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients aged between (18 - 25) years.
2. Mild crowding \< 4 mm in the lower dental arch with class I malocclusion
3. No congenitally missing or extracted teeth (except for third molars)
4. Patients with good oral hygiene.

Exclusion Criteria

1. Bimaxillary dentoalveolar protrusion.
2. Previous orthodontic treatment.
3. Severe skeletal discrepancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziad Mohamad Alhafi, DDS MSc

Role: PRINCIPAL_INVESTIGATOR

Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

Nada Rajeh, DDS MSc PhD

Role: STUDY_DIRECTOR

Department of Orthodontics, Faculty of Dentistry, Damascus University

Mohammad Younis Hajeer, DDS MSc PhD

Role: STUDY_CHAIR

Department of Orthodontics, Faculty of Dentistry, Damascus University

Locations

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Department of Orthodontics, University of Damascus Dental School

Damascus, , Syria

Site Status

Countries

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Syria

References

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Zhang M, McGrath C, Hagg U. The impact of malocclusion and its treatment on quality of life: a literature review. Int J Paediatr Dent. 2006 Nov;16(6):381-7. doi: 10.1111/j.1365-263X.2006.00768.x.

Reference Type BACKGROUND
PMID: 17014535 (View on PubMed)

Masood Y, Masood M, Zainul NN, Araby NB, Hussain SF, Newton T. Impact of malocclusion on oral health related quality of life in young people. Health Qual Life Outcomes. 2013 Feb 26;11:25. doi: 10.1186/1477-7525-11-25.

Reference Type BACKGROUND
PMID: 23443041 (View on PubMed)

Zhang B, Huang X, Huo S, Zhang C, Zhao S, Cen X, Zhao Z. Effect of clear aligners on oral health-related quality of life: A systematic review. Orthod Craniofac Res. 2020 Nov;23(4):363-370. doi: 10.1111/ocr.12382. Epub 2020 May 13.

Reference Type BACKGROUND
PMID: 32340082 (View on PubMed)

Azaripour A, Weusmann J, Mahmoodi B, Peppas D, Gerhold-Ay A, Van Noorden CJ, Willershausen B. Braces versus Invisalign(R): gingival parameters and patients' satisfaction during treatment: a cross-sectional study. BMC Oral Health. 2015 Jun 24;15:69. doi: 10.1186/s12903-015-0060-4.

Reference Type BACKGROUND
PMID: 26104387 (View on PubMed)

Kara-Boulad JM, Burhan AS, Hajeer MY, Khattab TZ, Nawaya FR. Evaluation of the Oral Health-Related Quality of Life (OHRQoL) in Patients Undergoing Lingual Versus Labial Fixed Orthodontic Appliances: A Randomized Controlled Clinical Trial. Cureus. 2022 Mar 22;14(3):e23379. doi: 10.7759/cureus.23379. eCollection 2022 Mar.

Reference Type BACKGROUND
PMID: 35371870 (View on PubMed)

Feu D, Oliveira BH, Celeste RK, Miguel JA. Influence of orthodontic treatment on adolescents' self-perceptions of esthetics. Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):743-50. doi: 10.1016/j.ajodo.2011.12.025.

Reference Type BACKGROUND
PMID: 22640676 (View on PubMed)

Palomares NB, Celeste RK, Oliveira BH, Miguel JA. How does orthodontic treatment affect young adults' oral health-related quality of life? Am J Orthod Dentofacial Orthop. 2012 Jun;141(6):751-8. doi: 10.1016/j.ajodo.2012.01.015.

Reference Type BACKGROUND
PMID: 22640677 (View on PubMed)

Other Identifiers

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UDDS-Ortho-2-2024

Identifier Type: -

Identifier Source: org_study_id

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